Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
86 participants
INTERVENTIONAL
2021-03-01
2026-01-01
Brief Summary
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Detailed Description
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Evaluate the effect of PAP adherence in children with DS and OSAS on patient-centered outcomes and family-relevant outcomes identified during the R61 phase of this research. It is being hypothesized that irrespective of study arm, increased PAP adherence will be associated with better patient-centered outcomes, and family-relevant outcomes identified during the first year of this research.
Determine the efficacy of INT vs. CON in promoting PAP adherence. It is being hypothesized that that children receiving INT will show significantly increased objectively-measured PAP adherence at 6 months compared with those receiving CON (Aim 4A). As a secondary aim (4B), it will be evaluated whether the improved adherence is maintained over 12 months. It is being hypothesized that participants initially randomized to the INT arm will have better adherence at 12 months compared to those in the CON arm.
Use mixed methods during the randomized controlled trial to identify family perceptions, such as empowerment and self-efficacy, regarding PAP use in youth with OSAS and DS. It is being hypothesized that INT-PAP will be associated with more positive perceptions compared to CON.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Family-informed intervention (INT)
Multiple face-to-face visits, telephone calls and-person visits with the PAP psychologist and team.
Family-informed intervention
Multiple face-to-face visits, telephone calls and-person visits with the PAP psychologist and team
Standard Clinical Care
Support which is given as part of the standard clinical care for patients who are currently prescribed PAP.
Standard Clinical Care
Support which is given as part of the standard clinical care for patients who are currently prescribed PAP.
Interventions
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Family-informed intervention
Multiple face-to-face visits, telephone calls and-person visits with the PAP psychologist and team
Standard Clinical Care
Support which is given as part of the standard clinical care for patients who are currently prescribed PAP.
Eligibility Criteria
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Inclusion Criteria
* Ages 6-18 years
* Children are able to cooperate with testing
* Naive to PAP treatment
Exclusion Criteria
* Family planning to move out of the city within the next year
* Children in foster care
* Child with previously treated with PAP
* Caregivers who do not speak English well enough to complete behavioral and performance measures.
6 Years
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Children's Hospital Medical Center, Cincinnati
OTHER
University of Pennsylvania
OTHER
University of Miami
OTHER
Responsible Party
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Locations
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University of Miami
Miami, Florida, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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Facility Contacts
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Other Identifiers
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